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Regulatory Focus™ > News Articles > Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

Posted 18 April 2017 | By Zachary Brennan 

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results.

A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Services, pay a $30,000 penalty and not own or operate a clinical laboratory for two years.

The company has come under fire since October 2015 after a Wall Street Journalinvestigation called into question its unapproved medical device with which the company was looking to revolutionize the blood testing industry.

Last September, FDA sent the California-based company a Form 483 for initiating clinical trials without the approval of an institutional review board. Theranos previously received two Form 483s for 14 different observations.

 

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